Impact of Spiroergometer Parameters as Diagnostic Marker of Cardiac Ischemia in Pts. With Stable Angina Compared to FFR. (ADVANCE)

August 10, 2022 updated by: Jena University Hospital

Impact of Ergospirometric Oxygen Uptake Under Exercise as Diagnostic Marker of Cardiac Ischemia in Patients With Stable Angina Compared to Non Invasive and Invasive (FFR) Measurement of Ischemia

In Patients with stable Angina pectoris CCS 1-3 exercise testing for ischemia detection is widely used despite the known limitations. Measurement of the FFR is invasive but gold standard for Ischemia detection.

Adding of parameters of spiroergometer might help to improve diagnostic accuracy of non invasive exercise testing. Therefore the trial is evaluating diagnostic accuracy of spiroergometric parameters compared to invasive FFR measurement.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with suspected CAD presenting for diagnostic testing/ coronary angiography

Description

Inclusion Criteria:

  • stable Angina (CCS >1-3) with suspected CAD or
  • dyspnoea at exertion NYHA >2 or
  • signs of ischemia within SPECT or exercise electrocardiography
  • willingness to participate in the trial

Exclusion Criteria:

  • Unstable angina or myocardial infarction within the last 2 weeks
  • inability to perform bicycle exercise test
  • significant valvular disease
  • HOCM
  • av- block >I degree
  • asthma bronchiales

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
double slope sign of ΔV̇O2/ΔWR-Increase
Time Frame: baseline
double slope sign of ΔV̇O2/ΔWR by ergospirometer test
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jena University Hospital

Investigators

  • Principal Investigator: Sven Möbius-Winkler, MD, Universityhospital Jena

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2019

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

June 25, 2020

First Submitted That Met QC Criteria

June 25, 2020

First Posted (Actual)

June 29, 2020

Study Record Updates

Last Update Posted (Actual)

August 11, 2022

Last Update Submitted That Met QC Criteria

August 10, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMW 08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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